genakumab (Gensci048) / GeneScience - LARVOL DELTA

Efficacy and safety of genakumab for first-line treatment of gout flare: A phase 2, multicenter, open-label, active controlled, randomized non-inferiority trial (EULAR 2025) - P2 | "Compared with daily oral etoricoxib, a single 200 mg subcutaneous injection of genakumab provides faster, more sustained relief of joint pain over 12 weeks, reduces recurrence risk, and is well tolerated as a first-line treatment for gout flares."

Clinical • Head-to-Head • P2 data • Dyslipidemia • Gout • Hypertriglyceridemia • Inflammatory Arthritis • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • Rheumatology • IL1B

Genakumab reduces the risk of acute gout flares during initiation of urate-lowering therapy: A phase 2, randomized, open-label, multi-center, active-controlled clinical trial (EULAR 2025) - P2 | "ULT options included oral allopurinol 100 mg/day, febuxostat 40 mg/day, or benzbromarone 50 mg/day. Genakumab demonstrated efficacy as a prophylaxis against acute gout flares in adults with gout initiating ULT and was generally well-tolerated. A single dose of genakumab 100 mg or 200 mg reduced the average number of acute gout flares per patient and shortened flare duration over 12 weeks, with a safety profile similar to daily colchicine. Notably, in the genakumab 200 mg group, gout flares were not observed for the entire 12-week period, a finding that will be further investigated in larger sample populations."

Clinical • P2 data • Dyslipidemia • Gout • Hypertriglyceridemia • Inflammatory Arthritis • Pain • Rheumatology • IL1B

Efficacy and Safety of Genakumab in Active Systemic Juvenile Idiopathic Arthritis (sJIA): A Multicenter, Randomized, Open-Label Phase 2 Clinical Study (EULAR 2025) - P=N/A | "Genakumab demonstrated comparable efficacy to tocilizumab with a favorable safety profile in the treatment of active sJIA. Common TEAEs were consistent with the expected effects of IL-1 receptor antagonists. Both doses of genakumab showed promising therapeutic effects, with a lower incidence of TEAEs compared to tocilizumab."

Clinical • P2 data • Anemia • Dyslipidemia • Hematological Disorders • Idiopathic Arthritis • Immunology • Infectious Disease • Metabolic Disorders • Respiratory Diseases • Rheumatology • IL1B • IL6

Clinical Study of Multiple Dose Genakumab for Injection in Chinese Healthy Adults (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

Clinical Study of Genakumab for Injection in Patients With Acute Gout (clinicaltrials.gov) - P1/2 | N=121 | Completed | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Gout • Inflammatory Arthritis • Rheumatology

A Bioequivalence Study of Two Different Dosage Form of Genakumab (clinicaltrials.gov) - P1 | N=178 | Completed | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Immunology • Inflammatory Arthritis • Rheumatology

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetic Profile of Genakumab Injection in Patients With Connective Tissue Disease-associated Interstitial Lung Disease (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Scleroderma • Systemic Sclerosis

Gensci 048-202: A Study of the Efficacy of Genakumab in Prevention of Acute Flares in Gout Patients Initiating Urate-lowering TherapyUrate-lowering (GenSci048-202) (clinicaltrials.gov) - P2 | N=165 | Completed | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | N=106 ➔ 165 | Trial completion date: May 2024 ➔ Jan 2024

Enrollment change • Trial completion date • Gout • Inflammatory Arthritis • Rheumatology

Efficacy and Safety of Genakumab versus Compound Betamethasone in Gout: The GUARD-1 Study (ACR Convergence 2024) - "In summary, in adults in whom NSAIDs and/or colchicine are contraindicated, are not tolerated, or do not provide an adequate response,Genakumab was demonstrated non-inferiority to Compound betamethasone in pain relief of gouty arthritis attacks, and superiority to Compound betamethasone within 12 weeks in delaying new flare which can be maintained until the end of the 24 weeks."

Clinical • Gout • Immunology • Inflammatory Arthritis • Pain • Rheumatology • IL1B

Safety & Efficacy of Genakumab in Patients With Frequent Flares (clinicaltrials.gov) - P3 | N=302 | Completed | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Jul 2024 ➔ Apr 2024 | Trial primary completion date: Oct 2023 ➔ Apr 2024

Trial completion • Trial completion date • Trial primary completion date • Gout • Inflammatory Arthritis • Rheumatology • CRP

Gensci 048-202: Safety and Efficacy of Genakumab for Injection in Patients With Gout Initiating Urico-lowering Therapy (clinicaltrials.gov) - P2 | N=106 | Completed | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Completed | Trial completion date: Feb 2024 ➔ May 2024

Trial completion • Trial completion date • Gout • Immunology • Inflammatory Arthritis • Rheumatology

Gensci 048-203: Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare (clinicaltrials.gov) - P2 | N=106 | Completed | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion • Gout • Inflammatory Arthritis • Rheumatology

A Bioequivalence Study of Two Different Dosage Form of Genakumab (clinicaltrials.gov) - P1 | N=178 | Active, not recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Inflammatory Arthritis • Rheumatology

To Evaluate the Efficacy and Safety of Genalumab for Injection in the Treatment of Active Systemic Juvenile Idiopathic Arthritis. (clinicaltrials.gov) - P=N/A | N=221 | Recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting | Phase classification: P2b ➔ PN/A | N=30 ➔ 221 | Trial completion date: Oct 2024 ➔ Jun 2028 | Trial primary completion date: Jul 2024 ➔ Mar 2028

Enrollment change • Enrollment open • Phase classification • Trial completion date • Trial primary completion date • Idiopathic Arthritis • Immunology • Rheumatology

A Bioequivalence Study of Two Different Dosage Form of Genakumab (clinicaltrials.gov) - P1 | N=178 | Recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

New P1 trial • Immunology • Inflammatory Arthritis • Rheumatology

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetic Profile of Genakumab Injection in Patients With Connective Tissue Disease-associated Interstitial Lung Disease (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

New P2 trial • Fibrosis • Immunology • Inflammatory Arthritis • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Scleroderma • Systemic Sclerosis

Gensci 048-203: Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare (clinicaltrials.gov) - P2 | N=106 | Recruiting | Sponsor: GeneScience Pharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Gout • Inflammatory Arthritis • Rheumatology

Gensci 048-203: Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare (clinicaltrials.gov) - P2 | N=106 | Not yet recruiting | Sponsor: GeneScience Pharmaceuticals Co., Ltd.

New P2 trial • Gout • Inflammatory Arthritis • Rheumatology

Gensci 048-202: Safety and Efficacy of Genakumab for Injection in Patients With Gout Initiating Urico-lowering Therapy (clinicaltrials.gov) - P2 | N=106 | Not yet recruiting | Sponsor: GeneScience Pharmaceuticals Co., Ltd.

New P2 trial • Gout • Immunology • Inflammatory Arthritis • Rheumatology

To Evaluate the Efficacy and Safety of Genalumab for Injection in the Treatment of Active Systemic Juvenile Idiopathic Arthritis. (clinicaltrials.gov) - P2b | N=30 | Not yet recruiting | Sponsor: GeneScience Pharmaceuticals Co., Ltd.

New P2b trial • Idiopathic Arthritis • Immunology • Rheumatology

Clinical Study of Multiple Dose Genakumab for Injection in Chinese Healthy Adults (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: GeneScience Pharmaceuticals Co., Ltd.

New P1 trial • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

Genakumab Alone and in Combination With Tislelizumab in Patients With Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: GeneScience Pharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CRP • CXCL8 • IL1B • IL6 • TNFA

Genakumab Alone and in Combination With Tislelizumab in Patients With Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=120 | Not yet recruiting | Sponsor: GeneScience Pharmaceuticals Co., Ltd.

Combination therapy • New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CRP • CXCL8 • IL1B • IL6 • TNFA

Clinical Study of Genakumab for Injection in Patients With Acute Gout (clinicaltrials.gov) - P1/2 | N=121 | Active, not recruiting | Sponsor: GeneScience Pharmaceuticals Co., Ltd.

New P1/2 trial • Gout • Inflammatory Arthritis • Rheumatology • CRP

Clinical Study of Genakumab for Injection in Chinese Healthy Volunteers (clinicaltrials.gov) - P1; N=40; Recruiting; Sponsor: GeneScience Pharmaceuticals Co., Ltd.

Clinical • New P1 trial